The present invention relates to collection bags, and more particularly to anti-reflux devices for such bags.
The systems in common use for urinary catheterization of a patient usually are provided with a catheter, a drainage tube, and a collection receptacle. The catheter is positioned in the patient with its distal end received in the patient's bladder and its proximal end extending outside the patient's body. The drainage tube is connected between the proximal end of the catheter and the collection receptacle. During catherization, urine drains through the catheter and drainage tube to the receptacle for collection. During recent years collection receptacles having flexible side walls have come into widespread use. Although such flexible receptacles or bags may have many advantages over the previously used rigid containers, a danger which has been attendant with the use of such bags is that pressure exerted against the side walls of the flexible bag may cause a reflux of urine from the bag into the drainage tube, and possibly the catheter and patient's bladder. The reflux of urine may be caused by the inadvertent bumping, squeezing, or tipping of the bag by a nurse, a physician, a visitor of the patient, or the patient himself. The urine which refluxes from the bag into the drainage tube causes an increase of pressure in the patient's bladder, and may result in trauma to the bladder. Additionally, the refluxing urine dramatically increases the possibility of retrograde bacterial movement from the bag to the patient's bladder, with possible deleterious results to the patient.
It has been proposed that a flexible valve be sealed around an inlet port communication between the tube and the bag to solve the reflux problem. However, it has been discovered that during sealing of the valve and subsequent sterilization of the bag the valve may become distorted, and, accordingly, may malfunction during later use.